REG - IQ-AI Limited - Application: FDA Breakthrough Therapy Designation

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RNS Number : 2234H  IQ-AI Limited  02 May 2025

IQ-AI Ltd

("IQ-AI" or the "Company")

 

Imaging Biometrics Applies for FDA Breakthrough Therapy Designation

May 2, 2025 - Imaging Biometrics, LLC (IB), a wholly owned subsidiary of IQ-AI
Ltd (LSE: IQAI), has today applied to the U.S. Food and Drug Administration
for 'Breakthrough Therapy Designation' for its innovative oral gallium
maltolate ("GaM") therapy.

 

The Phase 1 trial is evaluating oral GaM as a potential treatment for adult
patients with recurrent or refractory glioblastoma ("GBM") IDH-wildtype.
Preliminary findings suggest an overall survival ("OS") of 34.1 months from
initial diagnosis - whilst caution due to the size of the trial population is
appropriate, this significantly exceeds the median OS of 14-15 months (from
initial diagnosis) reported for patients undergoing standard of care treatment
(surgical resection, radiation, and chemotherapy).

 

Breakthrough Therapy Designation is granted to therapies that demonstrate
substantial improvement over existing treatments based on early clinical
evidence. While similar to the Fast Track Designation already received,
Breakthrough Therapy Designation provides more intensive FDA guidance and
senior-level organizational support. The FDA is required to respond to this
request within 60 days.

 

"Our decision to apply for Breakthrough Therapy Designation reflects our
optimism in the potential of oral GaM as a treatment for recurrent or
refractory glioblastoma ("GBM") IDH-wildtype " said Trevor Brown, CEO of IQAI.

--ENDS-

 

The Directors of the Company accept responsibility for the contents of this
announcement.

 

For further information, please contact:

 

 IQ-AI Ltd

 Trevor Brown/Dr Al Musella/Brett Skelly/Michael Schmainda

 Tel: 020 7469 0930
 Peterhouse Capital Limited (Financial Adviser and Broker)

 Lucy Williams/Heena Karani

 Tel: 020 7220 9797

 

About Imaging Biometrics® LLC:  IB is a wholly-owned subsidiary of IQ-AI
Limited, (LON: IQAI) (OTCQB: IQAIF), and focuses on delivering quantitative
imaging platforms and therapeutics that transform how clinicians diagnose and
treat patients more efficiently and effectively. For more information about
Imaging Biometrics, visit the company's website at www.imagingbiometrics.com
(http://www.imagingbiometrics.com/) . Follow IB on X, IQAI_IB.

 

 

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